MAUDE Adverse Event Report: GLAXOSMITHKLINE (GSK) VENTOLIN HFA METERED DOSE INHALER; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Reporter stated that he has copd takes a ventolin hfa inhaler.He said that it contains 144 metered inhalations but after "60 to 80 puffs" it no longer dispenses.He is concerned because his medication program only provides a 3 month supply and he is running out in half the time.

• Brand Name: VENTOLIN HFA METERED DOSE INHALER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): GLAXOSMITHKLINE (GSK)
• MDR Report Key: 9225875
• MDR Text Key: 163736196
• Report Number: MW5090589
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 75